More Frequent In-Center Hemodialysis in Pediatric End Stage Renal Disease

Hemodialysis Clinical Trial

Official title:

A Pilot Study of More Frequent In-Center Hemodialysis to Improve Outcomes in Pediatric End Stage Renal Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01352455
• Other study ID #: 2010-0596
• Status: Completed
• Phase: N/A
• First received: May 9, 2011
• Last updated: December 27, 2013
• Start date: March 2011
• Est. completion date: September 2013

Study information

• Verified date: December 2013
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A health kidney works 24 hours a day, 7 days a week to remove toxins and fluid from the body. Many children with permanent kidney failure undergo dialysis, a life saving procedure that takes the place of a kidney. Currently, many children with permanent kidney failure only receive dialysis treatments 3 days a week in the hospital dialysis clinic. Children on dialysis have a markedly reduced life expectancy, with a life span 40-50 years shorter than their healthy counterparts. Survival for these children has not improved over the last 20 years. These data indicate that the current dialysis treatment strategy is unacceptable.

This research project will study if more frequent dialysis, performed 5 days per week, will improve the health of children with permanent kidney failure compared to the current treatment strategy. Children will be treated with both traditional and more frequent dialysis schedules to measure improvements in their health and well being.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 21 Years

Eligibility

Inclusion Criteria:

• Current outpatient ESRD pediatric patients, 3-21 years old, receiving in-center chronic HD.

• Patients have to be on chronic HD for at least 2 months before eligibility

Exclusion Criteria:

• Patients with a scheduled (with a specific transplant date) kidney transplant in the next 6 months

• Patients scheduled to be switched to peritoneal dialysis in the next 6 months

• Patients currently receiving >3 days per week of hemodialysis

• Patients currently receiving >12 hours per week of hemodialysis

• Anyone <3 years of age would be excluded from the study, so our minimum anticipated patient weight would be about 11 kg

• Patients >21 years of age at enrollment

• Patients receiving concomitant peritoneal dialysis

• Patients with <2 months on chronic HD

• Patients with a temporary or femoral dialysis catheter

• Patients who are not hypertensive (both not on blood pressure medication and with a SBP <95th percentile for age, sex, and height)

• Patients enrolled in an investigational drug trial involving blood pressure medication or any other clinical trial potentially affecting the primary outcome of the study

Patients listed for a deceased donor transplant will not be excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodialysis
• Kidney Diseases
• Kidney Failure, Chronic
• Pediatric End Stage Renal Disease

Intervention

Procedure:
• Hemodialysis
5 days per week hemodialysis

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto
United States	Cincinnati Childrens Hospital Medical Center	Cincinnati	Ohio
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Children's Hospital Medical Center, Cincinnati, The Hospital for Sick Children

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure		up to 24 weeks	No
Secondary	Diastolic Blood Pressure		up to 24 weeks	No
Secondary	Treatment Costs		up to 24 weeks	No
Secondary	Quality of Life		up to 24 weeks	No
Secondary	Adverse Events/Symptoms		up to 24 weeks	Yes
Secondary	Bone Health		up to 24 weeks	No
Secondary	Anemia		up to 24 weeks	No
Secondary	Nutrition and Growth		up to 24 weeks	No
Secondary	Echocardiogram measured left ventricular mass		every 3 months	No
Secondary	School Performance		every 3 months	No
Secondary	Inflammatory Markers		every 3 months	No